European Medical Devices Regulations (MDR)

The Medical Device Regulation (MDR) is a set of EU rules aimed at ensuring the safety and effectiveness of medical devices, replacing previous directives with stricter requirements for classification, clinical evaluations, and post-market surveillance to enhance patient safety and market transparency. Transitional provisions in Article 120 allow devices compliant with previous directives to remain on the market until their CE Certificates expire, with an amendment (Regulation (EU) 2023/607) permitting certain legacy devices to stay available until December 31, 2028, under specific conditions.

Legacy devices fall into two categories: those with valid Directive Certificates and those needing Notified Body intervention. Manufacturers should prepare a rationale for their devices’ eligibility to address regulatory challenges. Key deadlines are May 26, 2024, for applying for MDR assessment, and September 26, 2024, for establishing a formal agreement with a Notified Body, with potential marketing consequences for missing these dates.